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Fluid Overload in Peritoneal Dialysis

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Aggressive fluid management
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PD patients with overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy

Exclusion Criteria:

  • overt pulmonary edema and required urgent medical care
  • cognitive impairment or problem of communication
  • unlikely to survive for more than three months
  • mechanical problems of the dialysis catheter
  • active peritonitis or peritoneal failure

Sites / Locations

  • Renal Unit, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Aggressive fluid management

Outcomes

Primary Outcome Measures

degree of overhydration
measured by bioimpedance spectroscopy

Secondary Outcome Measures

blood pressure
patient knowledge
questionnaire assessment

Full Information

First Posted
September 21, 2015
Last Updated
July 27, 2016
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02557347
Brief Title
Fluid Overload in Peritoneal Dialysis
Official Title
The Efficacy of Managing Fluid Overload in Peritoneal Dialysis Patient by a Structured Nurse-lead Intervention Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine the effectiveness of treating peritoneal dialysis (PD) patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment.
Detailed Description
Fluid overload is a common problem in peritoneal dialysis (PD) patients and it is associated with left ventricular hypertrophy and other adverse cardiac consequences. Fluid management is therefore an important aspect in the management of dialysis patient. In Hong Kong, PD patients with common medical problems related to dialysis are assessed and managed in the renal nurse clinic by pre-approved intervention protocols. Although it is the general impression that management of PD patients with fluid overload by a nurse-lead intervention protocol is robust and could reduce the work load of medical staff, the efficacy of this approach remains undetermined. The objective of this study is to determine the effectiveness of treating PD patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload, which is defined as overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol previously approved by the Hospital Authority. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment. Change in body weight, blood pressure, degree of oedema, as well as the knowledge on salt and fluid restriction will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Aggressive fluid management
Intervention Type
Behavioral
Intervention Name(s)
Aggressive fluid management
Intervention Description
nursing education, dietary advice, extra hypertonic dialysis cycles
Primary Outcome Measure Information:
Title
degree of overhydration
Description
measured by bioimpedance spectroscopy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
12 weeks
Title
patient knowledge
Description
questionnaire assessment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PD patients with overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy Exclusion Criteria: overt pulmonary edema and required urgent medical care cognitive impairment or problem of communication unlikely to survive for more than three months mechanical problems of the dialysis catheter active peritonitis or peritoneal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheuk Chun Szeto, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renal Unit, Prince of Wales Hospital
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

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Fluid Overload in Peritoneal Dialysis

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